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Sanofi Prioritizes Cancer And Rare Diseases In Pipeline Shake-Up

Sanofi has posted a solid if unspectacular set of financials for the fourth quarter but much more interesting was an update on the French major's R&D strategy and its increased focus on oncology, immunology and, having just got FDA approval for blood disorder drug Cablivi (caplacizumab), rare diseases.

Following the arrival from Roche of John Reed as its new head of R&D last summer, Sanofi said that it has carried out "a rigorous pipeline prioritization review to accelerate investment behind its most promising programs and to discontinue those with a less attractive expected return profile." As a result, Sanofi is fast-tracking 17 programs, including eight in oncology, while 13 development and 25 research projects are being discontinued "to enhance the company’s focus on delivering first and best in class medicines."

The R&D pipeline now contains 81 projects including 33 new molecular entities in clinical development, and 35 projects are in Phase III or have been submitted to regulatory authorities. Sanofi's annual R&D spend will be approximately €6bn annually through 2021.

A couple of priority programs center around Sanofi's CD38-targeting antibody isatuximab, which is set to be filed with regulatory authorities in the US and Europe in the second quarter of 2019 based on positive results from a Phase III trial in relapsed/refractory multiple myeloma, making it a possible challenger to Johnson & Johnson's blockbuster Darzalex (daratumumab). Sanofi noted that it has initiated Phase II trials for isatuximab in combination with its recently-launched PD-1/L1 inhibitor Libtayo (cemiplimab) in lymphoma; the latter, which is partnered with Regeneron Pharmaceuticals Inc. and is approved for cutaneous squamous cell carcinoma, had US sales of $15m in the fourth quarter.

Sanofi is also running a Phase II trial looking at a combination of isaruximab and Roche's PD-L1 inhibitor Tecentriq (atezolizumab) in solid tumors, while another Phase II has been initiated for SAR440340, an anti-IL33 monoclonal antibody which is being evaluated for atopic dermatitis. The company also noted that positive Phase I data for SAR408701, an anti-CEACAM5 antibody drug conjugate, in a subgroup of lung cancer patients, will lead to a broad development program starting before the end of 2019.

As for the discontinuations, a number of cardiovascular and metabolic disease assets were terminated, including SAR425899, a GLP-1/GCGR agonist which was in Phase II for obesity in type 2 diabetes patients, and SAR438335, a Phase I GLP-1/GIP agonist for diabetes. The moves highlight Sanofi's shift in focus from one of its historically strong areas – diabetes sales in the fourth quarter fell 10.5% to €1.38bn, due mainly to lower sales in the US of its insulin glargine products Lantus and Toujeo.

On a conference call, Reed said that the firm's approach to research will be "quick win, fail fast," with the objective of having 80% of the pipeline consisting of potential first or best in class candidates. About 70% of the pipeline will be biologics, with two-thirds of projects coming from internal R&D versus 50% at the moment and he added that Sanofi could potentially submit nine new medicines and 25 additional indications to regulatory authorities from 2019 to 2022.

Sanofi's enthusiasm for the rare diseases space, and particularly for its newly-formed rare blood disorder franchise, was vindicated Feb. 6 with FDA approval for its acquired thrombotic thrombocytopenic purpura (aTTP) therapy Cablivi (caplacizumab-yhdp), the main asset behind its €3.9bn acquisition of Belgium's Ablynx last year.